First-In-Human Phase 1 Study of a Nonwoven Fabric Bioabsorbable Spacer for Particle Therapy: Space-Making Particle Therapy (SMPT)
First-In-Human Phase 1 Study of a Nonwoven Fabric Bioabsorbable Spacer for Particle Therapy: Space-Making Particle Therapy (SMPT)
复制标题
DOI：
10.1016/j.adro.2019.05.002
复制
发表时间：
2019-10-01
影响因子：
2.3
通讯作者：
Fukumoto, Takumi
中科院分区：
文献类型：
--
作者：
Sasaki, Ryohei;Demizu, Yusuke;Fukumoto, Takumi
目的：外科间隔器放置（SSP）在粒子治疗（PT）中对邻近正常器官的腹部或盆腔肿瘤患者很有用。我们开发了一种由聚乙醇酸（PGA）缝线制成的非织造织物生物可吸收垫片，可通过水解降解。然后，我们使用PGA间隔区进行了SSP和PT组合的首次人体I期研究，我们称之为空间制造PT（SMPT）。本研究旨在评估SMPT的安全性和有效性与不可切除的恶性肿瘤患者位于邻近正常organs.Methods和材料：合格标准包括组织学证实的恶性腹部或盆腔肿瘤邻近肠，无转移，以前没有放射治疗。在SSP之前以及PT之前、期间和之后定期获得计算机断层扫描（CT）图像，直到间隔物消失。对每个CT图像集进行治疗计划，直至PT结束，并分析计划靶体积和风险器官的剂量。在每个CT图像集中测量PGA椎间融合器的厚度和体积。不良反应发生率按4.0版不良反应通用术语标准进行评价。结果：5例患者入组本研究。所有患者均接受了70.4戈伊（相对生物学有效性）的照射。SSP前、PT开始时和PT结束时计划靶体积的V-95%分别为82.1% +/-11.3%、98.1% +/-1.1%和97.1% +/-0.8%。所有患者的PGA间隔器在PT结束前保持足够的厚度（>= 1 cm），并在SSP后8个月内消失。结论：SMPT对邻近肠的腹部或盆腔肿瘤是可行和有用的。这种方法可能适用于位于正常器官附近的不可切除的肿瘤，并可能扩大PT的适应症。(C)2019作者（S）爱思唯尔公司出版代表美国放射肿瘤学会。
Purpose: Surgical spacer placement (SSP) is useful in particle therapy (PT) for patients with abdominal or pelvic tumors located adjacent to normal organs. We developed a nonwoven fabric bioabsorbable spacer made of polyglycolic acid (PGA) sutures that degrades via hydrolysis. We then conducted this first-in-human phase 1 study of the combination of SSP and PT using the PGA spacer, which we termed space-making PT (SMPT). This study aimed to evaluate the safety and efficacy of SMPT in patients with unresectable malignant tumor located adjacent to normal organs.Methods and Materials: The eligibility criteria included histologically proven malignant abdominal or pelvic tumor adjacent to the intestines, no metastasis, and no previous radiation therapy. Periodic computed tomography (CT) images were obtained before SSP and before, during, and after PT until the spacer disappeared. Treatment planning was performed for each CT image set until the end of PT, and doses for the planning target volume and organs at risk were analyzed. The thickness and volume of the PGA spacer were measured in each CT image set. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events version 4.0.Results: Five patients were enrolled in this study. All patients received 70.4 Gy (relative biological effectiveness) of irradiation. V-95% of the planning target volume before SSP, at the beginning of PT, and at the end of PT was 82.1% +/- 11.3%, 98.1% +/- 1.1%, and 97.1% +/- 0.8%, respectively. The PGA spacers maintained enough thickness (>= 1 cm) until the end of PT and disappeared within 8 months after SSP in all patients. No grade >= 3 acute adverse events were observed.Conclusions: The SMPT is feasible and useful for abdominal or pelvic tumors adjacent to the intestines. This method may be applicable to unresectable tumors located adjacent to normal organs and may expand the indications of PT. (C) 2019 The Author(s). Published by Elsevier Inc. on behalf of American Society for Radiation Oncology.